Dept. of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Hong Kong.
Vaccine. 2009 Dec 9;27(52):7428-35. doi: 10.1016/j.vaccine.2009.07.102. Epub 2009 Aug 13.
The immunogenicity and lot-to-lot consistency of an AS03-adjuvanted H5N1 vaccine were evaluated in 1206 Asian adults, randomised to receive two doses of adjuvanted (3.75 microg haemagglutinin) or diluent-mixed vaccines, 21 days apart. Post-Dose 2, 96.0% of vaccinees in the H5N1-AS03 group demonstrated a four-fold increase in neutralising antibody titres against the vaccine strain A/Vietnam/1194/2004 and 91.4% against strain A/Indonesia/05/2005. Haemagglutination-inhibiting antibodies (titre > or = 1:40) against A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains were observed in 94.3% and 50.2% of subjects, respectively. Lot-to-lot consistency of the AS03-adjuvanted vaccine combinations was demonstrated. The AS03-adjuvanted vaccine was well tolerated, induced a high frequency of immune responses to the vaccine strain, allowed antigen sparing and promoted cross-clade immunity. These characteristics make it suitable for presumptive use if an H5N1 pandemic were considered to be imminent.
在 1206 名亚洲成年人中评估了 AS03 佐剂的 H5N1 疫苗的免疫原性和批间一致性，这些成年人被随机分配接受两剂佐剂（3.75 微克血凝素）或稀释剂混合疫苗，间隔 21 天。在第 2 剂后，H5N1-AS03 组的 96.0%疫苗接种者对疫苗株 A/Vietnam/1194/2004 的中和抗体滴度增加了四倍，对 A/Indonesia/05/2005 株的中和抗体滴度增加了 91.4%。对 A/Vietnam/1194/2004 和 A/Indonesia/05/2005 株的血凝抑制抗体（滴度≥1:40）分别在 94.3%和 50.2%的受试者中观察到。证明了 AS03 佐剂疫苗组合的批间一致性。AS03 佐剂疫苗耐受性良好，诱导了对疫苗株的高频率免疫反应，允许抗原节省并促进了跨属免疫。如果认为 H5N1 大流行迫在眉睫，这些特征使其适合推测使用。
